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  FDA Links  

FDA Links -- About CDER/FDA News

 

 
  1. FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (natalizumab) (2/5/2010)
     
  2. FDA approves Xiaflex (collagenase clostridium histolyticum) for debilitating hand condition (2/3/2010)
     
  3. First-Time Generics - December 2009 (Updated: 2/3/2010)
     
  4. Postmarket Requirements and Commitments Database (updated 2/2/2010)
     
  5. MedWatch Alert - Zyprexa (olanzapine): Use in Adolescents (2/1/2010)
     
  6. FDA issued a Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine) (1/29/2010)
     
  7. Initiatives (Center for Drug Evaluation and Research) (1/28/2010)
     
  8. MedWatch Alert - Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment (1/26/2010)
     
  9. FDA approves Ampyra (dalfampridine) extended release tablets to improve walking in adults with multiple sclerosis (1/25/2010)
     
  10. UPDATED Public Health Alert: Counterfeit Alli containing sibutramine (1/22/2010)
     
  11. MedWatch Alert: Alli 60 mg capsules (120 count refill kit): Counterfeit product (1/19/2010)
     
  12. The Adverse Event Reporting System (AERS): Latest Quarterly Data Files (updated 1/19/2010)
     
  13. Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Dating (Posted: 1/15/2010)
     
  14. PREA Retrospective Review (PDF - 281KB) (1/14/2009)
     
  15. Follow-Up to the October 2008 Updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler) (1/14/2009)
     
  16. Fast Track Designation Request Performance (Updated: 1/12/2009)
     
  17. MedWatch Alert - Rapamune (sirolimus): Drug Monitoring Recommendations (1/11/2010)
     
  18. Presentations from Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools (November 12-13, 2009) (Posted 12/31/2009)
     
  19. FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy (12/31/2009)
     
  20. MedWatch Alert: Tylenol Arthritis Pain Caplet, 100 count bottles - Recall of all lots (Updated: 12/29/2009)
     
  21. Follow-Up to the August 2008 Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) - FDA Investigates a Report from the SEAS Trial (12/22/2009)
     
  22. Information for Healthcare Professionals - Mandatory Adverse Event Reporting for Emergency Use of Peramivir IV Under EUA (updated 12/18/2009)
     
  23. Drug Safety Oversight Board Meeting, Public Summary, November 16, 2009 (12/16/2009)
     
  24. Public Health Advisory: Availability of Tamiflu for Oral Suspension (12/14/2009)
     
  25. December 15, 2009: Vaccines and Related Biological Products Advisory Committee Briefing Documents  Roster and Draft Agenda posted (Posted: 12/11/2009)
     
  26. New Drug Review: 2009 Update, presentation by John K. Jenkins, M.D. Director, Office of New Drugs (PDF - 514 KB) (12/10/2009)
     
  27. MedWatch Alert: Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging (12/10/2009)
     
  28. Positron Emission Tomography (PET)  (Updated 12/9/2009)
     
  29. Prescription Drug User Fee Act: FY 2009 Clean-up Product and Establishment Fee Invoices were mailed on 12/9/2009  (Updated 12/9/2009)
     
  30. Approved Risk Evaluation and Mitigation Strategies (REMS) (updated 12/8/2009)
     
  31. Manual of Policies and Procedures (MaPP) 4657.3 (PDF - 217 KB)  Overtime Policy (updated 12/8/2009)
     
  32. MedWatch Alert: Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes (12/8/2009)
     
  33. FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary Angioedema (12/3/2009)
     
  34. FDA Drug Safety Newsletter - Volume 2, Number 3, 2009 (12/3/2009)
     
  35. Information for Healthcare Professionals: Risk of Neural Tube Birth Defects following prenatal exposure to Valproate (12/3/2009)
     
  36. MedWatch Alert for Norpramin (desipramine hydrochloride) (12/2/2009)
     
  37. FDA’s Woodcock Discusses Pain Management and Drug Safety in Nov. 26, 2009 Issue of The New England Journal of Medicine (11/30/2009)
  38.  
  39. Approved Active Moieties That Have Appeared On The National Institutes Of Health’s (NIH) Annual Priority List For Which FDA Has Issued A Written Request For Pediatric Studies Under The Best Pharmaceuticals For Children Act (BPCA) (updated 11/27/2009)
     
  40. Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride) (11/20/2009)
     
  41. Information for Healthcare Professionals: Peramivir IV Renal Dosing Recommendations (11/20/2009)
     
  42. MedWatch Safety Alert: Vicks Sinex Nasal Spray - Recall (11/20/2009)
     
  43. Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS) (updated 11/20/2009)
     
  44. Drug Safety Oversight Board Meeting, Public Summary, October 15, 2009 (11/19/2009)
     
  45. Information for Healthcare Professionals - Update to the labeling of Clopidogrel Bisulfate (marketed as Plavix) to alert healthcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC) (11/17/2009)
     
  46. Follow-Up to the January 26, 2009, Early Communication about an Ongoing Safety Review of Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC) (11/17/2009)
     
  47. Public Health Advisory: Updated Safety Information about a drug interaction between Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC) (11/17/2009)
     
  48. Pediatric Drug Development: Breakdown of FDAAA Completed Pediatric Studies (Updated: 11/16/2009)
     
  49. FDA approves Istodax (romidepsin) for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (11/10/2009)
     
  50. MedWatch Alert: Hospira Brand Propofol and Liposyn Products - Recall (11/10/2009)
     
  51. MedWatch Alert: Stiff Nights - product contains undeclared drug ingredient (11/6/2009)
     
  52. MedWatch Alert: Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall (11/6/2009)
     
  53. MedWatch Alert: Bodybuilding.com Brand Dietary Supplements - Sold on Internet (11/6/2009)
     
  54. Rulemaking History for Nonprescription Products: Labeling (11/6/2009)
     
  55. Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. Registration for this Nov. 14-15 meeting is closed. A free webcast will be available, no registration necessary. Webcast information (11/5/2009)
     
  56. FDA Unveils Safe Use Initiative that Targets Preventable Harm from Medication Use (11/4/2009)
     
  57. Information for Healthcare Professionals: Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta) (11/2/2009)
     
  58. CDER Manual of Policies and Procedures (MaPP) (Updated11/2/2009)
    1. 4300.1 CDER Medical Policy Coordinating Committee
    2. 5120.1R Office of Clinical Pharmacology Briefing Criteria and Attendance Policies
       
  59. MedWatch Alert on Rituxan (rituximab) and progressive multifocal leukoencephalopathy (PML) (10/26/2009)
     
  60. Information for Healthcare Professionals - Mandatory Adverse Event Reporting for Emergency Use of Peramivir Under EUA (10/23/2009)
     
  61. Approved Risk Evaluation and Mitigation Strategies (REMS) (updated 10/22/2009)
     

   

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